search
Back to results

A Coping Skills Program for Children With Asthma

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined coping skills + asthma management
Standard Asthma Management (AM)
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria are that (a) the child has a diagnosis of asthma as reported by the child's medical provider and confirmed by the parent; (b) the child is a current patient at a participating clinic; (c) the child is 8 to 14 years old; (d) the child is Latino/a; and (e) the child and parent speak English or Spanish.

Exclusion Criteria:

  • Exclusion criteria are that the presence of a disability interferes with the child's participation in the intervention beyond accommodations feasible in primary care.

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined coping skills + asthma management arm

Standard asthma management arm

Arm Description

The combined coping skills + asthma management arm is a family-based coping skills + asthma management intervention that is bilingual and culturally relevant for Latino families. This program is manualized with video-guided and interactive content to improve coping with stress and asthma management behaviors for both children and their parents. Coping strategies taught include primary and secondary control coping. Asthma management content is interactive and culturally tailored.

The standard asthma management (AM) arm is an asthma management intervention covering standard asthma self-management content (e.g., symptom recognition, self-monitoring). AM is manualized and is matched in length, time, and number of sessions to the experimental arm.

Outcomes

Primary Outcome Measures

Asthma Control as measured by the Asthma Control Test (ACT)
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Asthma Control as measured by the Asthma Control Test (ACT)
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Asthma Control as measured by the Asthma Control Test (ACT)
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Asthma Control as measured by the Asthma Control Test (ACT)
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.

Secondary Outcome Measures

Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Forced expiratory volume (FEV1) as measured by spirometry
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Forced expiratory volume (FEV1) as measured by spirometry
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Forced expiratory volume (FEV1) as measured by spirometry
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Forced expiratory volume (FEV1) as measured by spirometry
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Child self report of coping - Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.

Full Information

First Posted
October 14, 2021
Last Updated
March 24, 2023
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT05118282
Brief Title
A Coping Skills Program for Children With Asthma
Official Title
A Coping Skills Program for Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Uncontrolled asthma in school-aged children is a significant public health problem. Latino children living in low-income contexts are at increased risk for uncontrolled asthma compared to non-Latino white children, and stress is an unaddressed factor in this disparity. Therefore, the purpose of the current study is to test an intervention program that teaches families skills to cope with asthma-related and other sources of stress. Specifically, the study will compare the effects of the combined coping skills + asthma management program with a standard asthma management program in 280 families of Latino children with asthma. The study will also look at why the program may have an effect, and specifically whether the program impacts child coping, parent coping, or family asthma management behaviors. The main hypothesis is that the combined coping skills + asthma management program will improve asthma outcomes more than the standard asthma management program.
Detailed Description
This study is a randomized controlled trial (RCT) examining the effects and mediators of Adapt 2 Asthma (A2A), a coping skills + asthma management intervention, compared to standard asthma self-management (AM) for Latino children with asthma and their parents/caregivers living in low-socioeconomic status (SES) contexts. The focus of the study is to test the effects of A2A on asthma control, quality of life, lung function, school absences, and emergency department visits, and to identify child and parent mediational pathways of A2A. Children ages 8 to 14 years old with asthma and their parents/caregivers will participate. The investigators will enroll 280 youth who are patients at the partner primary care clinics and 280 of their parents/caregivers to participate. The investigators will identify patients with asthma in the study age range through reviewing records from the partner clinics as well as natural referral when patients attend appointments. The investigators will screen identified patients for eligibility. Enrolled families will complete assessments at 1 week pre-intervention, 1 week post-intervention, and at 6- and 12-month follow-up timepoints. Research staff will collect assessment data in the form of child and parent surveys, interviews and spirometry. Providers will also audiotape sessions, which will be used for case supervision and to measure fidelity to the intervention. Youth and parents/caregivers will provide all data. Participant data will be de-identified and stored in the principal investigator's locked laboratory, and all computerized data will be encrypted with University approved encryption software to ensure the confidentiality, integrity and availability of data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined coping skills + asthma management arm
Arm Type
Experimental
Arm Description
The combined coping skills + asthma management arm is a family-based coping skills + asthma management intervention that is bilingual and culturally relevant for Latino families. This program is manualized with video-guided and interactive content to improve coping with stress and asthma management behaviors for both children and their parents. Coping strategies taught include primary and secondary control coping. Asthma management content is interactive and culturally tailored.
Arm Title
Standard asthma management arm
Arm Type
Active Comparator
Arm Description
The standard asthma management (AM) arm is an asthma management intervention covering standard asthma self-management content (e.g., symptom recognition, self-monitoring). AM is manualized and is matched in length, time, and number of sessions to the experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
Combined coping skills + asthma management
Intervention Description
This arm includes a curriculum teaching coping skills and culturally relevant asthma management skills.
Intervention Type
Behavioral
Intervention Name(s)
Standard Asthma Management (AM)
Intervention Description
This arm includes a curriculum teaching standard asthma management skills.
Primary Outcome Measure Information:
Title
Asthma Control as measured by the Asthma Control Test (ACT)
Description
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Time Frame
Baseline
Title
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Description
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Time Frame
Baseline
Title
Asthma Control as measured by the Asthma Control Test (ACT)
Description
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Time Frame
1 week Post-intervention
Title
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Description
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Time Frame
1 week Post-intervention
Title
Asthma Control as measured by the Asthma Control Test (ACT)
Description
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Time Frame
6 months post-intervention
Title
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Description
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Time Frame
6 months post-intervention
Title
Asthma Control as measured by the Asthma Control Test (ACT)
Description
The Asthma Control Test assesses symptom control and impairment due to asthma (e.g., "how often have you had shortness of breath"). The ACT has versions for children ages 4-11 and 12 and older and is responsive to clinical change.
Time Frame
12 months post-intervention
Title
Asthma Control as measured by the Asthma Therapy Assessment Questionnaire (ATAQ)
Description
The Asthma Therapy Assessment Questionnaire (cATAQ) is a parent-report questionnaire; the symptom control subscale assesses children's asthma control (e.g., "wheezing or difficulty breathing") and shows good reliability and validity.
Time Frame
12 months post-intervention
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Description
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
Baseline
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Description
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
1 week post-intervention
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Description
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
6 months post-intervention
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Parent Report
Description
The PedsQL is a brief and standardized questionnaire that assesses parents' perceptions of health-related quality of life for children with chronic health conditions. Parents will complete the parent report of child. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
12 months post-intervention
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Description
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
Baseline
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Description
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
1 week post-intervention
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Description
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
6 months post-intervention
Title
Pediatric Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) Child Self Report
Description
The PedsQL is a brief and standardized questionnaire that assesses children's' perceptions of health-related quality of life for children with chronic health conditions. Children will complete the self-report version. Generic Core Scales of the PedsQL measure quality of life in physical, social, emotional and school domains (e.g., "it is hard for me to do chores around the house"; "it is hard to keep up when I play with other kids"), while the Asthma Module includes asthma-specific concerns related to symptoms and treatment (e.g., "I have trouble using my inhaler").
Time Frame
12 months post-intervention
Title
Forced expiratory volume (FEV1) as measured by spirometry
Description
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time Frame
Baseline
Title
Forced expiratory volume (FEV1) as measured by spirometry
Description
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time Frame
1 week post-intervention
Title
Forced expiratory volume (FEV1) as measured by spirometry
Description
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time Frame
6 months post-intervention
Title
Forced expiratory volume (FEV1) as measured by spirometry
Description
FEV1 is the amount of air an individual can force from their lungs in one second and is a measure of lung function in pediatric asthma. FEV1 will be measured using a spirometer. Child participants will forcefully exhale their maximal amount of air in one second. Participants will perform 3-8 forced expiration maneuvers and the mean of the best three measurements will be used.
Time Frame
12 months post-intervention
Title
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time Frame
Baseline
Title
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time Frame
1 week post-intervention
Title
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time Frame
6 months post-intervention
Title
School attendance as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's school absences related to asthma. Parent participants will report on the number of school absences in the past 6 months due to asthma.
Time Frame
12 months post-intervention
Title
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time Frame
Baseline
Title
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time Frame
1 week post-intervention
Title
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time Frame
6 months post-intervention
Title
Emergency Department visits as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's emergency department visits related to asthma. Parent participants will report on the number of emergency department visits due to asthma in the past 6 months.
Time Frame
12 months post-intervention
Title
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time Frame
Baseline
Title
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time Frame
1 week post-intervention
Title
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time Frame
6 months post-intervention
Title
Hospitalizations as measured by the Asthma Outcomes Questionnaire (AOQ)
Description
Parent participants will complete an Asthma Outcomes Questionnaire (AOQ) designed for this study to assess their child's hospitalizations related to asthma. Parent participants will report on the number of hospitalizations due to asthma in the past 6 months.
Time Frame
12 months post-intervention
Title
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time Frame
Baseline
Title
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time Frame
1 week post-intervention
Title
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time Frame
6 months post-intervention
Title
Parent coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent self-report form to assess their own coping.
Time Frame
12 months post-intervention
Title
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time Frame
Baseline
Title
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time Frame
1 week post-intervention
Title
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time Frame
6 months post-intervention
Title
Parent report of child coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Parents will complete the parent report of child form to assess their child's coping.
Time Frame
12 months post-intervention
Title
Child self report of coping - Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time Frame
Baseline
Title
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time Frame
1 week post-intervention
Title
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time Frame
6 months post-intervention
Title
Child self report of coping as measured by the Response to Stress Questionnaire (RSQ)
Description
The Response to Stress Questionnaire - Pediatric Asthma Version (RSQ) is a questionnaire with parallel forms for youth self-report, parent report of child, and parent self-report, and yields scores for Primary Control Coping and Secondary Control Coping. The RSQ is appropriate for ages 9 and older, has been validated cross-culturally, has strong psychometric properties, and shows sensitivity to change as a mediator of coping skills interventions. Children will complete the child self-report form to assess their own coping.
Time Frame
12 months post-intervention
Title
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Description
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time Frame
Baseline
Title
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Description
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time Frame
1 week post-intervention
Title
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Description
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time Frame
6 months post-intervention
Title
Family Asthma Management as measured by the Family Asthma Management Symptom Scale (FAMSS)
Description
The Family Asthma Management Symptom Scale (FAMSS) is a semi-structured clinical interview administered jointly to youth (school-aged and older) and parents to assess family asthma management. The FAMSS captures adherence to asthma self-management behaviors such as symptom monitoring, trigger avoidance, and medication and healthcare use within the context of the family. It shows good reliability and is correlated with objective measures of management such as electronically monitored adherence.
Time Frame
12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria are that (a) the child has a diagnosis of asthma as reported by the child's medical provider and confirmed by the parent; (b) the child is a current patient at a participating clinic; (c) the child is 8 to 14 years old; (d) the child is Latino/a; and (e) the child and parent speak English or Spanish. Exclusion Criteria: Exclusion criteria are that the presence of a disability interferes with the child's participation in the intervention beyond accommodations feasible in primary care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin M Rodriguez, PhD
Phone
512-471-0283
Email
erodriguez@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Garcia Cruz, BA
Phone
512-475-7363
Email
samantha.garciacruz@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin M Rodriguez, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin M Rodriguez, PhD
Phone
512-471-0283
Email
erodriguez@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Samantha Garcia Cruz, BA
Phone
512-475-7363
Email
samantha.garciacruz@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Coping Skills Program for Children With Asthma

We'll reach out to this number within 24 hrs